FREQUENTLY ASKED QUESTIONS
Answers to common questions about treating patients with Sogroya®.
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FREQUENTLY ASKED QUESTIONS
Answers to common questions about treating patients with Sogroya®.
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portrayal
General
Sogroya® is a human growth hormone (hGH) analog used as a once-weekly injectable medicine for children 2.5 years and older with growth failure due to inadequate secretion of endogenous growth hormone (GH), and for replacement of endogenous GH in adults with growth hormone deficiency.1 Please see full indications and learn more about how Sogroya® works.
Sogroya® is indicated for pediatric patients aged 2.5 years and older with growth failure due to inadequate secretion of endogenous growth hormone (GH), and for replacement of endogenous GH in adults with growth hormone deficiency (GHD).1 Please see full indications.
The active ingredient in Sogroya® is somapacitan-beco. Somapacitan-beco is a human growth hormone (hGH) analog with a single substitution in the amino acid backbone (L101C) to which an albumin-binding moiety has been attached.1
Somapacitan-beco binds to a dimeric GH receptor in the cell membrane of target cells resulting in intracellular signaling and a host of pharmacodynamic (PD) effects. Some of these PD effects are primarily mediated by insulin-like growth factor-1 (IGF-1) produced in the liver, while others are a result of the direct effects of somapacitan-beco.1
This reversible binding of somapacitan-beco to circulating albumin in the blood delays elimination of somapacitan-beco and results in prolonging the in vivo half-life and duration of action.1
This albumin-binding technology was developed by Novo Nordisk for other disease areas.1,2
It is an FDA requirement and is a distinguishing suffix that is devoid of meaning. The FDA asks manufacturers to use nomenclature like this to differentiate brands.
Please see the Prescribing Information for additional details. The most common side effects of Sogroya are different for pediatric and adult patients. They include1:
Pediatric GHD patients: Adverse reactions reported in ≥5% of patients treated with Sogroya® are: nasopharyngitis, headache, pyrexia, pain in extremity, and injection site reaction.
Adult GHD patients: Adverse reactions reported in >2% of patients treated with Sogroya® are: back pain, arthralgia, dyspepsia, sleep disorder, dizziness, tonsillitis, peripheral edema, vomiting, adrenal insufficiency, hypertension, blood creatine phosphokinase increase, weight increase, and anemia.
Sogroya® received FDA approval for the treatment of adult GHD in 2020 and for the treatment of pediatric GHD in April 2023.1
Taking Sogroya® (somapacitan-beco) injection
- Sogroya® pens may be stored in a refrigerator (from 36 °F-46 °F) until their expiration date
- After their first use, they may be stored in a refrigerator (from 36 °F-46 °F) for up to 6 weeks
- The pens may be stored at room temperature (≤77 °F) for a total of 72 hours regardless of whether opened and in use or unopened
- Do not freeze. Do not use Sogroya® if it has been frozen. If the storage temperature exceeds 86 °F, the pen must be discarded
- Avoid sunlight and direct or excessive heat1
Administer Sogroya® by subcutaneous injection to the upper arms, thigh, abdomen, or buttocks with regular rotation of injection sites to avoid lipohypertrophy/lipoatrophy.1 Learn how to inject and see the Prescribing Information for complete instructions.
Administer the prescribed dose subcutaneously one time each week.1 See pediatric dosing and adult dosing information.
If a patient misses a dose of Sogroya®, the dose can be taken within 3 days after the scheduled dosing day. Once-weekly dosing for the next dose could be resumed at the regularly scheduled dosing day.1
If more than 3 days have passed since the regular dosing day, patients should be instructed to skip that week’s dose and resume on the next regularly scheduled day.1
Switching patients from daily somatropin to once-weekly Sogroya® (somapacitan-beco) injection
Sogroya® is a once-weekly injectable medicine to replace growth hormone in both adults and children with growth hormone deficiency. It is a human growth hormone (hGH) analog with a single substitution in the amino acid backbone to which an albumin-binding moiety has been attached. The moiety is what gives Sogroya® its long-acting properties and ability to be dosed every week.1 Norditropin® doesn’t have this moiety and therefore isn’t a long-acting treatment.3
Sogroya® is available in 3 dosing strengths, each in a different pen: 5 mg/1.5 mL, 10 mg/1.5 mL, and 15 mg/1.5 mL.1
Sogroya® is indicated for pediatric patients aged 2.5 years and older with growth failure due to inadequate secretion of endogenous growth hormone (GH), and for replacement of endogenous GH in adults with growth hormone deficiency (GHD).
Norditropin® is a recombinant human growth hormone used as a once-daily injectable treatment. Norditropin® is used to treat a variety of growth disorders including pediatric patients with growth failure due to inadequate secretion of endogenous growth hormone (GH) and Prader-Willi Syndrome; short stature associated with Noonan Syndrome, Turner Syndrome, and children born small for gestational age; idiopathic short stature; and for the replacement of endogenous GH in adults with growth hormone deficiency (GHD).3
Norditropin® is available in 4 dosing strengths, each in a different pen: 5 mg/1.5 mL, 10 mg/1.5 mL, 15 mg/1.5 mL, and 30 mg/1.5 mL.3
Both Sogroya® and Norditropin® are delivered with the FlexPro® device platform.1,3,4
The Sogroya® pen is based on the FlexPro® you know.3-6 Both pens are prefilled, require no mixing or reconstitution, and feature precise dosing increments. The Sogroya® pen is stable at room temperature (up to 77 °F) for up to 72 hours. Norditropin® is stable at room temperature (up to 77 °F) for up to 3 weeks after first use.1,3
There are no plans for Norditropin® to be discontinued.
Resources for HCPs
Additional resources are available for you and your colleagues.
Additional resources are available for you and your colleagues.
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Important Safety Information for Sogroya®
Contraindications
Sogroya® is contraindicated in patients with:
- acute critical illness after open-heart surgery, abdominal surgery, multiple accidental trauma, or acute respiratory failure because of the risk of increased mortality with use of Sogroya®
- hypersensitivity to Sogroya® or any of its excipients. Systemic hypersensitivity reactions have been reported postmarketing with somatropin
- pediatric patients with closed epiphyses
- active malignancy
- active proliferative or severe non-proliferative diabetic retinopathy
- pediatric patients with Prader-Willi syndrome who are severely obese, have a history of upper airway obstruction or sleep apnea, or have severe respiratory impairment due to risk of sudden death
Warnings & Precautions
- Increased Mortality in Patients with Acute Critical Illness: Increased mortality has been reported after treatment with somatropin in patients with acute critical illness due to complications following open-heart surgery, abdominal surgery, multiple accidental trauma, and in patients with acute respiratory failure
Indications and Usage
Sogroya® (somapacitan-beco) injection 5 mg, 10 mg, or 15 mg is indicated for the:
- treatment of pediatric patients aged 2.5 years and older who have growth failure due to inadequate secretion of endogenous growth hormone (GH)
- replacement of endogenous GH in adults with growth hormone deficiency (GHD)
Important Safety Information
Contraindications
Sogroya® is contraindicated in patients with:
- acute critical illness after open-heart surgery, abdominal surgery, multiple accidental trauma, or acute respiratory failure because of the risk of increased mortality with use of Sogroya®
- hypersensitivity to Sogroya® or any of its excipients. Systemic hypersensitivity reactions have been reported postmarketing with somatropin
- pediatric patients with closed epiphyses
- active malignancy
- active proliferative or severe non-proliferative diabetic retinopathy
- pediatric patients with Prader-Willi syndrome who are severely obese, have a history of upper airway obstruction or sleep apnea, or have severe respiratory impairment due to risk of sudden death
Warnings & Precautions
- Increased Mortality in Patients with Acute Critical Illness: Increased mortality has been reported after treatment with somatropin in patients with acute critical illness due to complications following open-heart surgery, abdominal surgery, multiple accidental trauma, and in patients with acute respiratory failure
- Severe Hypersensitivity: Serious systemic hypersensitivity reactions including anaphylactic reactions and angioedema have been reported postmarketing with use of somatropin. Inform patients and/or caregivers that such reactions are possible, and that prompt medical attention should be sought if an allergic reaction occurs
- Increased Risk of Neoplasms: There is an increased risk of malignancy progression with somatropin in patients with active malignancy. Any preexisting malignancy should be inactive, and its treatment complete prior to instituting Sogroya®. In childhood cancer survivors treated with radiation to the brain/head for their first neoplasm who developed subsequent GHD and were treated with somatropin, an increased risk of a second neoplasm has been reported. Monitor patients with a history of GHD secondary to an intracranial neoplasm for progression or recurrence of the tumor. Children with certain rare genetic causes of short stature have an increased risk of developing malignancies and should be carefully monitored for development of neoplasms. Monitor patients for increased growth or potential malignant changes of preexisting nevi. Advise patients/caregivers to report changes in the appearance of preexisting nevi
- Glucose Intolerance and Diabetes Mellitus: Treatment with somatropin may decrease insulin sensitivity, particularly at higher doses. New onset type 2 diabetes has been reported. Monitor glucose levels in all patients, especially in those with existing diabetes mellitus or with risk factors for diabetes mellitus, such as obesity, Turner syndrome or a family history of diabetes mellitus. The doses of antidiabetic agents may require adjustment when Sogroya® is initiated
- Intracranial Hypertension: Has been reported usually within 8 weeks of treatment initiation. Perform fundoscopic examination prior to initiation of treatment and periodically thereafter. If papilledema is identified, evaluate the etiology, and treat the underlying cause before initiating Sogroya®. If papilledema is observed, stop treatment. If intracranial hypertension is confirmed, Sogroya® can be restarted at a lower dose after intracranial hypertension signs and symptoms have resolved
- Fluid retention: May occur during Sogroya® therapy. Clinical manifestations of fluid retention (e.g. edema and nerve compression syndromes including carpal tunnel syndrome/paresthesia) are usually transient and dose dependent
- Hypoadrenalism: Patients receiving somatropin therapy who have or are at risk for corticotropin deficiency may be at risk for reduced serum cortisol levels and/or unmasking of central (secondary) hypoadrenalism. Patients treated with glucocorticoid replacement for previously diagnosed hypoadrenalism may require an increase in their maintenance or stress doses following initiation of Sogroya®. Monitor patients with known hypoadrenalism for reduced serum cortisol levels and/or need for glucocorticoid dose increases
- Hypothyroidism: Undiagnosed/untreated hypothyroidism may prevent an optimal response to Sogroya®. Monitor thyroid function periodically as hypothyroidism may occur or worsen after initiation of Sogroya®
- Slipped Capital Femoral Epiphysis in Pediatric Patients: Slipped capital femoral epiphysis may occur more frequently in patients undergoing rapid growth. Evaluate pediatric patients with the onset of a limp or complaints of persistent hip or knee pain
- Progression of Preexisting Scoliosis in Pediatric Patients: Monitor patients with a history of scoliosis for disease progression
- Pancreatitis: Cases of pancreatitis have been reported in patients receiving somatropin. The risk may be greater in pediatric patients compared to adults. Consider pancreatitis in patients with persistent severe abdominal pain
- Lipohypertrophy/Lipoatrophy: May occur if Sogroya® is administered at the same site over a long period of time. Rotate injection sites to reduce this risk
- Sudden death in Pediatric Patients with Prader-Willi Syndrome: There have been reports of fatalities after initiating therapy with somatropin in pediatric patients with Prader-Willi syndrome who had one or more of the following risk factors: severe obesity, history of upper airway obstruction or sleep apnea, or unidentified respiratory infection. Male patients with one or more of these factors may be at greater risk than females. Sogroya® is not indicated for the treatment of pediatric patients who have growth failure due to genetically confirmed Prader-Willi syndrome
- Laboratory Tests: Serum levels of inorganic phosphorus and alkaline phosphatase may increase after Sogroya® therapy. Serum levels of parathyroid hormone may increase with somatropin treatment
Adverse Reactions
- Pediatric patients with GHD: Adverse reactions reported in ≥5% of patients are nasopharyngitis, headache, pyrexia, pain in extremity, and injection site reaction
- Adult patients with GHD: Adverse reactions reported in >2% of patients are back pain, arthralgia, dyspepsia, sleep disorder, dizziness, tonsillitis, peripheral edema, vomiting, adrenal insufficiency, hypertension, blood creatine phosphokinase increase, weight increase, and anemia
Drug Interactions
- Glucocorticoids: Patients treated with glucocorticoid for hypoadrenalism may require an increase in their maintenance or stress doses following initiation of Sogroya®
- Cytochrome P450-Metabolized Drugs: Sogroya® may alter the clearance. Monitor carefully if used with Sogroya®
- Oral Estrogen: Patients receiving oral estrogen replacement may require higher Sogroya® dosages
- Insulin and/or Other Antihyperglycemic Agents: Dose adjustment of insulin and/or antihyperglycemic agent may be required for patients with diabetes mellitus
Please click here for Sogroya® Prescribing Information.
Selected Important Safety Information for Norditropin®
Contraindications
Norditropin® is contraindicated in patients with:
- Acute critical illness after open heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure due to the risk of increased mortality with use of pharmacologic doses of somatropin
- Pediatric patients with Prader-Willi syndrome who are severely obese, have a history of upper airway obstruction or sleep apnea, or have severe respiratory impairment due to the risk of sudden death
- Active Malignancy
- Hypersensitivity to Norditropin® or any of its excipients. Systemic hypersensitivity reactions have been reported with postmarketing use of somatropin products
- Active proliferative or severe non-proliferative diabetic retinopathy
- Pediatric patients with closed epiphyses
Indications and Usage
Norditropin® (somatropin) injection is indicated for the treatment of pediatric patients with:
- growth failure due to inadequate secretion of endogenous growth hormone (GH)
- short stature associated with Noonan syndrome,
- short stature associated with Turner syndrome,
- short stature born small for gestational age (SGA) with no catch-up growth by age 2 to 4 years of age
- Idiopathic Short Stature (ISS), height standard deviation score (SDS) <-2.25, and associated with growth rates unlikely to permit attainment of adult height in the normal range
- growth failure due to Prader-Willi syndrome (PWS)
Norditropin® is also indicated for the replacement of endogenous GH in adults with growth hormone deficiency (GHD)
Important Safety Information
Contraindications
Norditropin® is contraindicated in patients with:
- Acute critical illness after open heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure due to the risk of increased mortality with use of pharmacologic doses of somatropin
- Pediatric patients with Prader-Willi syndrome who are severely obese, have a history of upper airway obstruction or sleep apnea, or have severe respiratory impairment due to the risk of sudden death
- Active Malignancy
- Hypersensitivity to Norditropin® or any of its excipients. Systemic hypersensitivity reactions have been reported with postmarketing use of somatropin products
- Active proliferative or severe non-proliferative diabetic retinopathy
- Pediatric patients with closed epiphyses
Warnings and Precautions
- Increased mortality in patients with acute critical illness due to complications following open heart or abdominal surgery or multiple accidental trauma, or those with respiratory failure has been reported.
- Sudden death in pediatric patients with Prader-Willi Syndrome has been reported after initiating treatment with somatropin with one or more of the following risk factors: severe obesity, history of upper airway obstruction or sleep apnea, or unidentified respiratory infection. Evaluate patients for signs of upper airway obstruction and sleep apnea before initiation of treatment.
- Increased risk of neoplasms: Monitor patients with preexisting tumors for progression or recurrence. In childhood cancer survivors who were treated with radiation to the brain/head for their first neoplasm and who developed subsequent GHD and were treated with somatropin, an increased risk of a second neoplasm, in particular meningiomas, has been reported. Pediatric patients with certain rare genetic causes of short stature have an increased risk of developing malignancies and should be carefully monitored for development of neoplasms. Monitor patients carefully for increased growth, or potential malignant changes, of preexisting nevi.
- Glucose intolerance and diabetes mellitus: Treatment with somatropin may decrease insulin sensitivity, particularly at higher doses. New-onset type 2 diabetes mellitus has been reported. Monitor glucose levels in all patients. Doses of concurrent antidiabetic drugs may require adjustment.
- Intracranial hypertension has been reported in a small number of patients, usually within the first 8 weeks of somatropin treatment. Funduscopic examination should be performed before initiating treatment and periodically thereafter.
- Severe hypersensitivity: Serious systemic hypersensitivity reactions including anaphylactic reactions and angioedema have been reported with postmarketing use of somatropin products.
- Fluid retention in adults (clinically manifesting as edema, arthralgia, myalgia, nerve compression syndromes including carpal tunnel syndrome/paraesthesias) may frequently occur and is usually transient and dose-dependent.
- Hypoadrenalism: Patients who have or are at risk for pituitary hormone deficiency(s) may be at risk for reduced serum cortisol levels and/or unmasking of central (secondary) hypoadrenalism. In addition, patients treated with glucocorticoid replacement for previously diagnosed hypoadrenalism may require an increase in their maintenance or stress doses following initiation of Norditropin® treatment.
- Hypothyroidism if undiagnosed/untreated, may prevent an optimal response to Norditropin®, in particular, the growth response in pediatric patients. In patients with GHD, central (secondary) hypothyroidism may first become evident or worsen during somatropin treatment. Periodic thyroid function tests and thyroid hormone replacement therapy should be initiated or adjusted when indicated.
- Slipped capital femoral epiphysis in pediatric patients may occur more frequently in patients with endocrine disorders or in patients undergoing rapid growth. Pediatric patients with the onset of a limp or complaints of hip or knee pain should be evaluated.
- Progression of preexisting scoliosis in pediatric patients can occur in patients who experience rapid growth. Patients with a history of scoliosis should be monitored for progression.
- Pancreatitis: Cases of pancreatitis have been reported. Pancreatitis should be considered in any patient who develops persistent severe abdominal pain.
- Lipoatrophy: Tissue atrophy may result when somatropin is administrated subcutaneously at the same site over a long period of time. Rotate injection sites when administering Norditropin® to reduce this risk.
Adverse Reactions
- Other common adverse reactions in adults and pediatric patients include: upper respiratory infection, fever, pharyngitis, headache, otitis media, edema, arthralgia, paresthesia, myalgia, peripheral edema, flu syndrome, and impaired glucose tolerance
Drug Interactions
- Glucocorticoids: Patients treated with glucocorticoid for hypoadrenalism may require an increase in their maintenance or stress doses following initiation of Norditropin®
- Pharmacologic Glucocorticoid Therapy and Supraphysiologic Glucocorticoid Treatment: Adjust glucocorticoid replacement dosing in pediatric patients receiving glucocorticoid treatment to avoid both hypoadrenalism and an inhibitory effect on growth
- Cytochrome P450-Metabolized Drugs: Norditropin® may alter the clearance. Monitor carefully if used with Norditropin®
- Oral Estrogen: Larger doses of Norditropin® may be required
- Insulin and/or Other Hypoglycemic Agents: Dose adjustment of insulin or hypoglycemic agent may be required
Use in Specific Populations
- Pregnancy and Nursing Mothers: There are limited data with somatropin use in pregnant women and nursing mothers to inform a drug-associated risk for adverse developmental outcomes.
- Geriatric Use: The safety and effectiveness in patients aged 65 and over has not been evaluated in clinical studies.
Please click here for Norditropin® Prescribing Information.
References:
- Sogroya [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2023.
- Johansson E, Nielsen AD, Demuth H, et al. Identification of binding sites on human serum albumin for somapacitan, a long-acting growth hormone derivative. Biochemistry. 2020;59(14):1410-1419.
- Norditropin [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2020.
- Data on file. Novo Nordisk, Inc.; Plainsboro, NJ.
- Johannsson G, Gordon MB, Rasmussen MH, et al. Once-weekly somapacitan is effective and well tolerated in adults with GH deficiency: a randomized phase 3 trial. J Clin Endocrinol Metab. 2020;105(4):e1358-e1376.
- Miller BS, Blair JC, Rasmussen MS, et al. Weekly somapacitan is effective and well tolerated in children with GH deficiency: the randomized phase 3 REAL4 trial. J Clin Endocrinol Metab. 2022;107(12):3378-3388.